11 December 2023
11 December 2023
The FDA draft guidance on diabetes efficacy endpoints has elicited positive response, but stakeholders and experts stress reasonability.
Novartis is seeking approval for Kisqali as a treatment of early breast cancer, with an FDA application planned for submission by the end of this year.
In the trial, 54.5% of trial subjects did not have any bleeding cases that needed treatment following Hemlibra dosing.
The study will continue to assess the other co-primary endpoint of assessing PFS with receiving Opdivo plus Yervoy compared to Opdivo alone.
Danicopan demonstrated to be well tolerated in the trial without any new safety issues reported.
Ezharmia’s safety profile in the trial was in line with prior clinical studies.
Epcoritamab resulted in ORR and CR of 82% and 63%, respectively, at a median follow-up period of 17.4 months.
Pfizer has added the EU to its growing number of markets for its targeted immunotherapy intended for relapsed/refractory multiple myeloma (RRMM).
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